Vice President, Head of Nonclinical Development and Translational Medicine

  • 200 Cambridge Park Dr, Cambridge, MA 02140, USA
  • Full-time

Company Description

Precision therapeutics for genetically defined diseases. Real solutions for real challenges.

Who We Are

Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, CGT9486 (formerly PLX9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.

Job Description

Cogent is looking for a dynamic individual to lead our Nonclinical Development and Translational Medicine organization.  The individual will lead strategy and oversee technical execution across the areas of clinical pharmacology, nonclinical Drug Safety, and translational medicine.  This position will be a key team member in the research and development organization and will be a vital part of helping to achieve the Cogent vision: to discover, develop, and commercialize best-in-class therapies that have a dramatic impact for patients with genetically defined diseases.  Cogent is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment.

 

What You Will Do

  • Reporting to the Chief Medical Officer, you will be focused on the following activities:
  • Lead Drug Metabolism and Pharmacokinetics (DMPK), Clinical Pharmacology, nonclinical drug safety evaluation, and development and implementation of a biomarker strategy for precision small molecules
  • Develop and execute scientifically rigorous strategies to inform drug discovery, development and regulatory decisions through all phases of drug development
  • Demonstrate drive, visibility and influence in key company decisions including development candidate selection, patient dosage selection, clinical strategy, and regulatory filing strategy.
  • Leverage internal and external expertise and your own network to draft, plan, implement, and execute against organizational objectives
  • Demonstrate an understanding of risk assessment and drive strategies to manage risk across your multiple departmental dimensions
  • Actively partner with Clinical Development, Clinical Operations, and CMC functions in driving asset and company strategy to fruition
  • Oversee CRO selection, mentorship, and activities, build external consultant networks and setting the right balance of internal versus external capabilities
  • Contribute to driving the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies

Qualifications

What You Bring

  • PhD and/or MD MD/PhD, DVM PhD and experience in one or preferably more of DMPK, clinical pharmacology, pharmacometrics, nonclinical toxicology and pharmaceutics disciplines with at least 10 years of relevant and current technical and leadership experience.
  • Experience leading and applying pharmacometric approaches such as population PK, PKPD, and disease progression models to support research and development
  • Excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, drug-drug interactions, drug transporters, quantitative systems pharmacology, mechanistic toxicology risk assessment, and pharmaceutics in a cutting edge discipline.
  • Documented experience in drug development process including multiple regulatory submissions
  • Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information succinctly
  • Excellent analytical and problem-solving skills and ability to manage multiple projects and initiatives simultaneously in a fast-paced environment
  • Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams

Additional Information

 

Our Location

Cogent is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

  • Cogent is an equal opportunity employer
  • Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals